Z-2295-2011

Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent...

Name: Z-2295-2011 Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent...
Creator: Newport Medical Instruments Inc
Published: 2009-01-13
License: https://open.fda.gov/license/

Newport Medical Instruments, Inc. / initiated 2009-01-13 / Terminated / root cause: labeling and UDI

FDA source

Newport Medical Instruments Inc began a recall of Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent mechanical ventilator support for the care of... on 2009-01-13. The reason FDA records is "The recall was initiated because Newport Medical Instruments confirmed that the Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that reminds users to keep...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2295-2011
Status: Terminated
Initiated: 2009-01-13
Posted: 2011-05-26
Terminated: 2011-06-01
Recalling firm: Newport Medical Instruments, Inc.
Product: Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs), who require the following general types of ventilatory support.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The recall was initiated because Newport Medical Instruments confirmed that the Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Newport Medical Instruments, Inc. sent an FIELD CORRECTION letter dated January 13, 2009, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. The Newport HT50 ventilators that were shipped in December 2008, were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery. The customer were also requested to complete the attached customer REWORK INSTRUCTIONS form and fax it to (714) 427-0489. If you have any further questions, please call (714) 427-5811 x 344
Distribution: Worldwide Distribution-- USA including states of OH, VA, WA, WI and country of Turkey.
Product codes and lots: Device Listing Number: D0004206 Serial Numbers: N08HT501212491 through N08HT501212523

Product code CBK

K992133Class IINewport Ht50 Ventilator with Humidifier Ht50-H, Newport Ht50 Ventilator without Humidifier, Ht50-H1, Newport Ht50 VentilNewport Medical Instruments, Inc. / cleared 2000-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)